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FDA 510(k)

SYSTEM 86 COMPUTERIZED LUNG VOL. SPIROME

K-Number: K810243 · 1981-02-12

ApplicantCardio Pulmonary Instruments
Decision Date1981-02-12
Product CodeBZC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SYSTEM 86 COMPUTERIZED LUNG VOL. SPIROME is the device name listed in this FDA 510(k) record. The listed applicant is Cardio Pulmonary Instruments. It received FDA 510(k) clearance on 1981-02-12 under 510(k) number K810243. The device is classified under product code BZC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYSTEM 86 COMPUTERIZED LUNG VOL. SPIROME?

SYSTEM 86 COMPUTERIZED LUNG VOL. SPIROME is a medical device that received FDA 510(k) clearance on 1981-02-12. The listed applicant is Cardio Pulmonary Instruments. The 510(k) number is K810243.

When did SYSTEM 86 COMPUTERIZED LUNG VOL. SPIROME receive FDA 510(k) clearance?

SYSTEM 86 COMPUTERIZED LUNG VOL. SPIROME received FDA 510(k) clearance on 1981-02-12, under 510(k) number K810243.

Who is the listed applicant for SYSTEM 86 COMPUTERIZED LUNG VOL. SPIROME?

The FDA 510(k) record lists Cardio Pulmonary Instruments as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYSTEM 86 COMPUTERIZED LUNG VOL. SPIROME?

The FDA product code for SYSTEM 86 COMPUTERIZED LUNG VOL. SPIROME is BZC.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Cardio Pulmonary Instruments as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K810196SYSTEM 84 COMPUTERIZED LUNG VOL. SPIROMK803255AUTOMATED PULMONARY FUNCTION LABORATORY

Related Devices (Code: BZC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240293STSTechbopulm, Ltd.K183567Vyntus/SentrySuite Product LineVyaire MedicalK190853Vyntus BODYVyaire Medical, Inc.K181524Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CARTVyaire Medical, Inc.K162515COSMED K5 Wearable Metabolic TechnologyCosmed SrlK161295MiniBox +Pulmone Advanced Medical Devices, Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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